FDA.reportPublic FDA data

n.a.

Primary DI
04048551366844
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
11274BCU1
Device description
CYSTOSCOPE ONLY,PEDIATRIC,
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551366844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551366844040485513668444048551366844

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic cystoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, and to remove tissue samples/stones/small tumours from the bladder. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Ethylene Oxide"", ""Peracetic Acid"", ""Liquid Chemical""]"
Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid;Liquid Chemical

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048438000175NAKarl Storz GmbH & Co. KGFBO2025-03-27
04048551431382n.a.Karl Storz GmbH & Co. KGFBO2024-11-28
04953170438158Biopsy ValveOLYMPUS MEDICAL SYSTEMS CORP.FBO2023-04-22
04953170451980Luer-Split MAJ-2092OLYMPUS MEDICAL SYSTEMS CORP.FBO2022-08-05
04055207066218E-LINERichard Wolf GmbHFBO2020-02-21
04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390146n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
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00821925001374Gyrus ACMIGyrus ACMI, LLCFBO2016-10-13
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00821925001947Elite BipolarGyrus ACMI, LLCFBO2016-10-13
00821925011229Elite IglesiasGyrus ACMI, LLCFBO2016-10-13
00821925008229USA Elite Gyrus ACMI, LLCFBO2016-10-05
00821925008243EliteGyrus ACMI, LLCFBO2016-10-05
00821925027275Gyrus ACMIGyrus ACMI, LLCFBO2016-10-05
04055207018385NARichard Wolf GmbHFBO2016-09-29
04055207018392NARichard Wolf GmbHFBO2016-09-29
04055207018491NARichard Wolf GmbHFBO2016-09-29
04055207018194MOXYRichard Wolf GmbHFBO2016-09-27
04055207018231GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018255GREENLIGHTRichard Wolf GmbHFBO2016-09-27